Postpartum DepressionPhase 2MOMNCT00795652
Mom: Managing Our Mood, Part of The Family Help Program
A Phase 2 study testing Distance Treatment for postpartum depression in people with Postpartum Depression, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of the MOM: Managing Our Mood Program (part of Family Help) is to evaluate the effectiveness of the Family Help distance intervention compared to usual or standard care typically provided to women with mild to moderate postpartum depression symptomology. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Distance Treatment for postpartum depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completed diagnostic measure (SCID), reviewed and signed off by a psychologist
- Participant must meet DSM-IV criteria for postpartum depression
- Significant depressive symptoms that have been present for at least 2 weeks
- Participant must be within 1-12 months postpartum
- Participant must have ready private access to a telephone
- Participant must be between 19-45 years old
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- Participant has provided verbal telephone consent
- Participants must speak, read and write in English
- If they are taking medication they must be stabilized (have been on the medication for at least four weeks).
Who cannot join
- Any condition that in the judgment of the psychologist may interfere with effective delivery of the treatment program (ie, Severe symptomology, challenging diagnostic dilemmas, families who are unmotivated or are in complete chaos)
- Current reports of specific suicidal intentions
- Actively suicidal; suicidal attempts in the previous 6 months
- Participants who are not willing to commit to the demands of treatment
- Participants who have had psychological treatment in the past 6 months for similar problems.
- Participants who have a history of psychotic disorders
Show all 9Show fewer
- Participants who are cognitively impaired
- Participants who are involved with child protection services
- Participants who have significant substance dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program
The purpose of the MOM: Managing Our Mood Program (part of Family Help) is to evaluate the effectiveness of the Family Help distance intervention compared to usual or standard care typically provided to women with mild to moderate postpartum depression symptomology. This is a single-center trial based at the IWK Health Center. The primary outcome is change in postpartum depression diagnosis.
Read the detailed description
The Family Help- MOM: Managing Our Mood Program is to deliver, primary care mental health services to mothers in the comfort and privacy of their own home. The purpose of this randomized control trial is to test the effectiveness of the Managing Our Mood (MOM) postpartum depression distance treatment program. This study is a single-centre trial based at the IWK Health Centre, similar to other Family Help Modules.
The goal of this study is to determine the effectiveness of the MOM cognitive-behavioural intervention as an alternative treatment for women suffering from postpartum depression. The intervention is delivered at a distance, using educational materials (handbooks, video-tapes/DVDs, and telephone consultation with a trained paraprofessional coach. Family Help coaches deliver consistent care based on written protocols, with on-going evaluation by a professional team. MOM is not designed to replace specialist care of complex multi-problem mothers.
Eligible participants will be randomly assigned to either active MOM treatment or to the Best Efforts control condition. Those participants assigned to Best Efforts receive printed information about postpartum depression that describes the illness, how it is caused and various treatment options; they are assigned a Coach who books their assessments and is available to answer any questions; they are encouraged to maintain contact and regular care with their family physician or public health nurse for both themselves and their baby. At the end of the 12-month follow-up (one year from randomization), these women will be offered the opportunity to take part in the MOM treatment if they are still depressed.
- Conditions
- Postpartum Depression
- Being tested
- Distance Treatment for postpartum depression
- Keywords
- Postpartum depression, Distance therapy, depression, Distance Treatment, Barriers to care
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance Treatment for postpartum depressionBehavioural
Also called Family Help Program (listed below: other Modules registered), Pediatric Anxiety (2234a) NCT00267566, Pediatric Disruptive Behaviour (2234b) NCT00267579, Pediatric ADHD NCT00267605
Evidence-based, cognitive behavioural intervention for women with postpartum depression
| Study group | Role | What they receive |
|---|---|---|
| Distance Treatment | Experimental | 50% randomized to receive Distance Treatment for postpartum depression Receives: Behavioral: Distance Treatment for postpartum depression |
| Usual Care Services | No intervention | 50% randomized to receive usual care services for postpartum depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis with SCID (Semi-structured diagnostic interview)
Measured: baseline, 120, 240, 365
Secondary outcomes (4)
Edinburgh Postnatal Depression Scale
Measured: baseline, 120, 240, 365
Sheehan Disability Scale
Measured: Baseline, 120, 240, 365
Satisfaction measure, designed by the investigator
Measured: end of intervention
Beck Depression Inventory-II
Measured: baseline, 120, 240 and 365 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startMay 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Patrick J McGrath, PhD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795652
- Sponsor's protocol ID
- 3556
- Acronym
- MOM
- Status last verified
- Sep 2016
- First submitted
- 19 Nov 2008
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate summary data would be made available but not individual data.
Publications
Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
PubMed 18632994Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
PubMed 18025870Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
PubMed 17227604McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
PubMed 19270846Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
PubMed 18632997
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based, Distance Treatment for Postpartum Depression, Mom: Managing Our Mood, Part of The Family Help Program
- ClinicalTrials.gov ID
- NCT00795652
- Acronym / sponsor ID
- MOM / 3556
- Conditions
- Postpartum Depression
- Keywords
- Postpartum depression, Distance therapy, depression, Distance Treatment, Barriers to care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the MOM: Managing Our Mood Program (part of Family Help) is to evaluate the effectiveness of the Family Help distance intervention compared to usual or standard care typically provided to women with mild to moderate postpartum depression symptomology. This is a single-center trial based at the IWK Health Center. The primary outcome is change in postpartum depression diagnosis.
Detailed description
The Family Help- MOM: Managing Our Mood Program is to deliver, primary care mental health services to mothers in the comfort and privacy of their own home. The purpose of this randomized control trial is to test the effectiveness of the Managing Our Mood (MOM) postpartum depression distance treatment program. This study is a single-centre trial based at the IWK Health Centre, similar to other Family Help Modules.
The goal of this study is to determine the effectiveness of the MOM cognitive-behavioural intervention as an alternative treatment for women suffering from postpartum depression. The intervention is delivered at a distance, using educational materials (handbooks, video-tapes/DVDs, and telephone consultation with a trained paraprofessional coach. Family Help coaches deliver consistent care based on written protocols, with on-going evaluation by a professional team. MOM is not designed to replace specialist care of complex multi-problem mothers.
Eligible participants will be randomly assigned to either active MOM treatment or to the Best Efforts control condition. Those participants assigned to Best Efforts receive printed information about postpartum depression that describes the illness, how it is caused and various treatment options; they are assigned a Coach who books their assessments and is available to answer any questions; they are encouraged to maintain contact and regular care with their family physician or public health nurse for both themselves and their baby. At the end of the 12-month follow-up (one year from randomization), these women will be offered the opportunity to take part in the MOM treatment if they are still depressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distance Treatment | Experimental | Behavioral: Distance Treatment for postpartum depression50% randomized to receive Distance Treatment for postpartum depression |
| Usual Care Services | No intervention | –50% randomized to receive usual care services for postpartum depression |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Completed diagnostic measure (SCID), reviewed and signed off by a psychologist
- Participant must meet DSM-IV criteria for postpartum depression
- Significant depressive symptoms that have been present for at least 2 weeks
- Participant must be within 1-12 months postpartum
- Participant must have ready private access to a telephone
Key exclusion criteria (9 listed)
- Any condition that in the judgment of the psychologist may interfere with effective delivery of the treatment program (ie, Severe symptomology, challenging diagnostic dilemmas, families who are unmotivated or are in complete chaos)
- Current reports of specific suicidal intentions
- Actively suicidal; suicidal attempts in the previous 6 months
- Participants who are not willing to commit to the demands of treatment
- Participants who have had psychological treatment in the past 6 months for similar problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distance Treatment for postpartum depressionAlso: Family Help Program (listed below: other Modules registered), Pediatric Anxiety (2234a) NCT00267566, Pediatric Disruptive Behaviour (2234b) NCT00267579, Pediatric ADHD NCT00267605Evidence-based, cognitive behavioural intervention for women with postpartum depression | Behavioural | Distance Treatment |
Primary outcome
Diagnosis with SCID (Semi-structured diagnostic interview)
Time frame: baseline, 120, 240, 365
4 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: baseline, 120, 240, 365
Sheehan Disability Scale
Time frame: Baseline, 120, 240, 365
Satisfaction measure, designed by the investigator
Time frame: end of intervention
Beck Depression Inventory-II
Time frame: baseline, 120, 240 and 365 day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Background: PubMed 18632994Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
- Background: PubMed 18025870Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
- Background: PubMed 17227604Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
- Background: PubMed 19270846McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
- Background: PubMed 18632997Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
- Individual participant dataSharing planned: No. Aggregate summary data would be made available but not individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J McGrath, PhD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Distance Treatment for postpartum depression in people with Postpartum Depression, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis with SCID (Semi-structured diagnostic interview) (time frame: baseline, 120, 240, 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00795652, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.